Consent

The University of Pittsburgh has created a toolkit for researchers to help them disclose Alzheimer’s-related biomarker results.

This article provides a framework for planning disclosure and consent procedures for research studies involving participants with dementia.

In this review article, researchers discuss the ethical aspects to consider when recruiting people with dementia for clinical trials.

People with Alzheimer’s disease are vulnerable to therapeutic misconception, particularly, the conflation of routine clinical care and scientific research. This misconception can compromise the informed consent process by causing prospective participants to underappreciate the level of risk involved in trial participation. The authors advocate for a more comprehensive informed consent process that accounts for the uniqueness of Alzheimer’s disease, creates a more productive and clear...

The Michael J. Fox Foundation, which focuses on elimination of Parkinson’s disease, has developed study recruitment materials that are applicable to other areas of disease research.

Two articles and an editorial address the question of whether paying research participants could be considered coercive. The first article notes concerns about risks, consent, and exploitation. The second article examines coercion as subjection, in which someone’s interests can be partially set back in virtue of being subject to another’s foreign will. The editorial weighs the arguments and views participation as work that should be fairly compensated. Malmqvist E. “Paid to endure”: Paid...

The NIH website, NIH Clinical Trials and You, contains several pages for researchers and trial sites: Improving Visibility of NIH-Supported Clinical Trial Activities and Results: Describes the NIH policy, similar to the FDA “Final Rule” reporting requirement for funded clinical trials: Trials must be registered at ClinicalTrials.gov, and summary results must be submitted no later than 1 year after the primary completion date. Clearly Communicating Research Results Across the Clinical Trials...

This paper describes the design and development of a tablet-based decision support tool to enhance shared decision making and decisional capacity for people with a genetic condition that causes development problems and cognitive impairment who are participating in the informed consent process.

This toolkit, developed by the National Center for Advancing Translational Sciences at the National Institutes of Health, provides patient groups with the tools needed to advance medical research. Tools are developed for and by patient groups in concert with their academic, government, industry, and advocacy partners, and are designed to ensure patients are engaged as essential partners from beginning to end of the research and development process. Resources cover topics such as the principles...

Strengthening Translational Research in Diverse Enrollment (STRIDE) is a collaborative project focused on developing innovative approaches to enhancing informed consent procedures, with a goal of improving research literacy among underserved populations.